Arrhythmia Prediction Trial

Brief Title

Arrhythmia Prediction Trial

Official Title

Arrhythmia Prediction Trial and Risk Stratification in Heart Failure Patients - Athens.

Brief Summary

      Patients with Ischaemic and Dilated Cardiomyopathy, face an increased risk for Arrhythmic
      Sudden Cardiac Death. The purpose of this study is to estimate the performance of Modern
      Non-Invasive Indices and the performance of Programmed Ventricular Stimulation in Sudden
      Cardiac Death Prediction.
    

Detailed Description

      Sudden Cardiac Death (SCD) threatens survival of Coronary Artery Disease and Dilated
      Cardiomyopathy patients with Heart Failure. Discovering efficient SCD risk stratification
      markers is of high importance. In this study, heart failure patients will be risk stratified
      with indices from the Myocardial substrate (QRS, fragmented QRS, Late potentials, LVEF),
      indices from the Repolarization status (QT duration, QT rate corrected , QT dispersion,
      QT/RR, T wave Amplitude Variability, T wave alternans, QT Variability Index), indices from
      the Autonomic Nervous System function [ Heart Rate variability, Heart rate Turbulence,
      Deceleration Capacity (DC) , DC sign of fraction, Beat to Beat DC, Non linear indices of
      Heart Rate Dynamics], the Non sustained ventricular tachycardia and Ventricular extrasystolic
      activity and the Circadian Properties of Heart Rate observed during Ambulatory Monitoring.
      Furthermore Programmed Ventricular Stimulation will be used. High resolution 30 min ECG
      recordings will performed for further indices research and development. All the Arrhythmic
      Risk Stratifiers will be analysed and their performance for Sudden Cardiac Death Prediction
      and for Total Mortality will be estimated according the follow up.
    

Study Type

Observational

Primary Outcome

Sudden Cardiac Death surrogates: 1.Clinical Ventricular Tachyarrhythmia, 2.ICD's appropriate activation, 3.Confirmed Sudden Cardiac Death

Secondary Outcome

 Total Mortality

Condition

Myocardial Infarction

Study Arms / Comparison Groups

 SCD possitive versus SCD negative group

Description:  The total Heart Failure patients subgroup experiencing Sudden Cardiac Death surrogate end-points during follow up versus the patients subgroup that is free from Sudden Cardiac Death surrogate end-points.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Estimated Enrollment

500

Start Date

October 2007

Completion Date

June 2019

Primary Completion Date

June 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Myocardial Infarction

          -  Dilated Cardiomyopathy

          -  Sinus rhythm

        Exclusion Criteria:

          -  Malignant diseases seriously affecting the survival

          -  Conditions/diseases affecting the Autonomic Nervous System's function

          -  Dementia

          -  Alcoholism

          -  Psychiatric diseases

          -  Addiction
      

Gender

All

Ages

20 Years - 82 Years

Accepts Healthy Volunteers

No

Contacts

Petros Arsenos, MD, PhD, 00306974338896, [email protected]

Location Countries

Greece

Location Countries

Greece

NCT ID

NCT02175836

Organization ID

17/25-10-2006

Secondary IDs

APRET, Athens Medical School

Responsible Party

Principal Investigator

Study Sponsor

University of Athens

Study Sponsor

Petros Arsenos, MD, PhD, Principal Investigator, First Department of Cardiology, Medical School, National & Kapodistrian University of Athens, Greece

Verification Date

January 2016